Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA

NAEnrolling by invitationINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

March 28, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Aortic Stenosis
Interventions
DIAGNOSTIC_TEST

Videodensitometric guided

"In the experimental arm, a TAVI device is implanted according to the local practice. Immediately after implantation, aortography is performed to quantitatively assess the aortic regurgitation (qAR). The aortography is analyzed using CAAS A-Valve (Pie-Medical, Maastricht, The Netherlands).~•If qAR is \>17%, we recommend that corrective post-TAVI manoeuvres (post-dilatation, valve-in-valve, etc.) will be performed and angiography is repeated for the assessment of aortic regurgitation. If the qAR ≤17%, whether corrective post-TAVI manoeuvres (post-dilatation, valve-in-valve, etc.) will be performed is left to the discretion of the operators. Inform operators of the results of qAR and the threshold criteria. Continuous qAR was stratified into categorical variables according to the following pre-determined threshold criteria: (1) none or trace (qAR \<6%); (2) mild (6% to ≤17%); and (3) moderate or severe (\>17%).~At discharge, all the patients will undergo Cardiac magnetic resonance, the Car"

DIAGNOSTIC_TEST

Stand of care guided

"In the control arm, a TAVI device is implanted according to local practice. Immediately after implantation, TEE/TTE or aortography is performed as a part of usual practice.~* The requirement of post-dilatation or any additional procedure is left to the discretion of the operator.~* The operator judges the sufficient procedural outcome to end the procedure according to local practice.~At discharge, all the patients will undergo Cardiac magnetic resonance, the Cardiac magnetic resonance-derived regurgitation fraction (CMR-RF) will be analyzed as the primary endpoint."

Trial Locations (2)

71000

Xijing hospital, Xi'an

200032

Zhongshan hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Xijing Hospital

OTHER